Prediabetes Intervention With Tea (PREVENT)

Instituto Politécnico de Bragança

Status: Invitation-only

Conditions: Pre Diabetes; Diabetes Mellitus, Type 2

Treatments: Behavioral: Lifestyle behavior change program (LBC); Other: Olive Leaf Tea; Other: Placebo tea

Study type: Interventional

Funder types: Other

Identifiers

NCT05583045

83/2022

Details and patient eligibility

About

The goal of this interventional study is investigating the effect of the daily consumption of olive leaves tea on glycemic control of individuals diagnosed with pre-diabetes. The hypothesis of this study is that the integration of olive leaf tea on daily food consumption will favors glycemic control and ameliorate insulin resistance in individuals with pre-diabetes.

Full description

This study is a triple-blinded, randomized, placebo-controlled trial with parallel assignment

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

At least one of three glycemic criteria for pre diabetes as defined by 2022 American Diabetes Association (ADA) guidelines:

• Fasting plasma glucose level, 100 to 125 mg per deciliter (5.6 to 6.9 mml per liter);
• Plasma glucose level 2 hours after a 75-g oral glucose load, 140 to 199 mg per deciliter (7.8 to 11.0 mml per liter);
• Glycated hemoglobin level, 5.7 to 6.4% (39 to 47 mml per mole).

Exclusion criteria

• Current use of medication for lowering blood cholesterol, glucose or hypertension;
• History of chronic or severe diseases that may affect study outcomes or limit study participation;
• Pregnancy and breastfeeding

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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140 participants in 2 patient groups, including a placebo group

Olive Leaf Tea (OLT)

Experimental group

Description:

Daily intake, for 12 weeks, of olive leaf tea + lifestyle behavior change program.

Treatment:

Behavioral: Lifestyle behavior change program (LBC)

Other: Olive Leaf Tea

Placebo tea (CON)

Placebo Comparator group

Description:

Daily intake, for 12 weeks, of placebo tea + lifestyle behavior change program

Treatment:

Behavioral: Lifestyle behavior change program (LBC)

Other: Placebo tea